BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE 32

    MDR report key: 16962787 · Received May 19, 2023

    Report

    Report Number
    3006630150-2023-02831
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    April 21, 2023
    Report Date
    May 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729832676
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC, UPN: M365SC14320, MODEL: SC-1432, SERIAL: (B)(6), BATCH: 213421.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEG FATIGUE AND BLADDER INCONTINENCE. CT SCAN CONFIRMED BLEEDING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WAS DISPOSED AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623269 COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8336-70 7073174 08714729832676

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Hospitalization| R